New Resource Sheds Light on FDA CDRH Regulatory Focus

By MedTech Intelligence Staff

Unhappy with current textbooks and resources for regulatory professionals, Elijah Wreh, Professor of Regulatory Science and Senior Manager Regulatory Affairs at Boston Scientific, authored his own book for industry and future regulators.

Industry Survey:
Literature Review Automation Adoption Insights and Trends

Sponsored By DistillerSR

DistillerSR, in partnership with Citeline, surveyed global professionals in the medical device and in-vitro diagnostics industry to understand organizational preparedness and management maturity towards literature review practices.

Download to learn more

Regulatory Intelligence:
Meeting the Demands of Today’s Global Regulatory Market

By MedTech Intelligence Staff

The increase in global regulatory demands for medical devices has presented new challenges for regulatory affairs and intelligence teams. On May 16-17, The MedTech Regulatory Intelligence Summit will bring together regulatory professionals, device developers and regulators to look at current trends in FDA and international pre-market and post-market requirements, as well as key pain points in achieving regulatory compliance throughout the product lifecycle.

The Importance of High-Quality Communication in the Healthcare Setting

By Chris Talbot, Spectralink

Unified communication systems can improve staff efficiency, while enhancing patient outcomes and staff and patient safety.

MedTech Regulatory Intelligence:
Post-Market Surveillance

Sponsored By HUMA.AI and Rimsys

Post-market surveillance has become an increasingly important area of focus in both U.S. FDA and EU regulations. In this webinar, we take a closer look at the challenges of developing sustainable post-market surveillance processes, as well as how companies are addressing these challenges and using new tools to track product safety and performance post market. With Queenita Fernandes of Medtronic, Robert Di Giovanni of Novartis, Ashley Kelleher of NSF, Adam Price of Rimsys and Lana Feng of HUMA.AI.

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Integrating Games into Medical Devices To Improve Patient Outcomes

By Lorenzo Gutierrez, Ph.D., StarFish Medical

Imagine a patient undergoing therapy being relaxed and enjoying the treatment, or receiving rewards for taking medicine religiously and on time. Creating a game-like experience can change patient perception of medical devices from boring or scary to engaging and attractive. This article covers ways to integrate gaming features into your medical devices, why games are so enticing and how they impact human behavior.

Featured Quote

Flexibility is necessary, but if founders aren’t careful, they risk losing control of their engineering process along the way.

— Jeff Thompson, MD and Urvashi Bhatnagar

Terumo Enables Global Collaboration and Clinical Excellence for Groundbreaking Medtech Research

Sponsored By Veeva Medtech

Terumo, global leader in medical technology, transforms to a unified, digital approach to manage global clinical trials and operations. Read this article to learn about the approach, processes, infrastructure changes, and impact on the business.

AI Medical Device Software Under the MDR

Sponsored By DNV

This paper reviews some key aspects of safety and performance assessments of AI medical device software according to the existing regulation (EU) 2017/745 (MDR) ahead of the upcoming regulatory updates and standards publication. It also provides a review of requirements to be addressed in order to bring an SaMD to market.

MedTech Intelligence 2023 Washington DC Conferences

More info at MedTechIntelligence.com

May 16-17
MedTech Regulatory Intelligence Summit
The MedTech Regulatory Intelligence Summit brings together RA/QA professionals, device developers and regulators to share experiences and best practices, and find solutions to the key pain points in achieving regulatory compliance throughout the product lifecycle.
Learn more and register here.

May 18-19
ConnectedCare Summit East
The ConnectedCare Summit East brings together entrepreneurs, innovators, researchers and regulators as we examine what’s next—and what’s holding us back—on the road to a truly connected healthcare system.
Learn more and register here.

November 7-8
MedTech Intelligence Advanced Manufacturing Conference
Join leading MedTech engineers and manufacturers as we take an in-depth look at the use of advanced manufacturing technologies in quality improvement, speeding time to market and combating labor shortages, and share insights on what’s working, implementation challenges and strategies for successful adoption. (Registration opening soon)

November 8-9
MedTech Supply Chain Intelligence Summit
Gain insight and strategies from procurement professionals, device manufacturers and regulators on how to assess and mitigate risks to the supply chain, improve logistics, and build and maintain a sustainable, resilient supply chain. (Registration opening soon)